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Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy

NCT ID: NCT01632670

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this study is to determine the effect of music therapy before, during, and after cardiac catheterization is associated on (a) change in reactive hyperemia index measured before and after catheterization using peripheral arterial tonometry and (b) patient stress and discomfort measured by a questionnaire, as compared to the standard of care (no music during cardiac catheterization).

The hypothesis of the study is that music therapy during cardiac catheterization will be associated with more favorable change in reactive hyperemia and higher patient satisfaction compared to no music playback.

Detailed Description

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Conditions

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Coronary Artery Disease Endothelial Dysfunction

Keywords

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music cardiac catheterization endothelial function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Music therapy

The music played will be by MusiCure, by Niels Eje (slow, relaxing music designed for therapeutic use), and will be played from an audio pillow beneath the patient's head.

Group Type EXPERIMENTAL

Music therapy

Intervention Type OTHER

The music played will be by MusiCure, by Niels Eje (slow, relaxing music designed for therapeutic use), and will be played from an audio pillow beneath the patient's head.

No music therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music therapy

The music played will be by MusiCure, by Niels Eje (slow, relaxing music designed for therapeutic use), and will be played from an audio pillow beneath the patient's head.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age \>18 years
2. Referred for clinically-indicated cardiac catheterization

Exclusion Criteria

1. Refusal or inability to provide signed informed consent
2. Significant hearing loss
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emmanouil Brilakis

FED

Sponsor Role lead

Responsible Party

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Emmanouil Brilakis

Director, Cardiac Catheterization Laboratories

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Emmanouil S Brilakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

North Texas Veterans Healthcare System

Locations

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Dallas VA Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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12-027

Identifier Type: -

Identifier Source: org_study_id